Shining 3D Aoralscan 3 Manuale utente

Aoralscan 3

Manual

V1.0.0.30

Aoralscan 3_Manual_V1.0.0.30 - 1 -

Foreword

General

The Manual (hereinafter referred to as "the Manual") introduces the functions, installation,

usage and maintenance of the Aoralscan 3 (hereinafter referred to as "the Scanner").

Safety Instructions

Signal

Meaning

Additional information for particular situation.

Improper actions or conditions that may damage the product or injury, and

consequently void your warranty or service contract or lose the patient data or

system data.

The safety instructions that you must precisely follow in order to avoid injury. Failure

to observe can cause damages to your product, or result in personal injuries, or even

death.

Revision History

No.

Version

Revision Content

Release Date

V1.0.0.30

Add various types of operational safety

precautions required by regulatory information.

August, 2021

V1.0.0.0

First release.

November, 2019

About the Manual

may be reproduced, transmitted, transcribed, stored in a retrieval system or translated

into any language or computer language, in any form or by any means, electronic,

mechanical, magnetic, optical, chemical, manual or otherwise, without the prior written

permission of Shining3D Corporation.

⚫All other logos, products, or company names mentioned in the Manual may be the

registered trademarks or copyrights of their respective companies, and are used for

informational purposes only.

⚫Shining 3D Tech Co., Ltd makes no representations or warranties, either expressed or

implied, with respect to the contents hereof and specifically disclaims any warranties,

Aoralscan 3_Manual_V1.0.0.30 - 2 -

merchantability or fitness for any particular purpose. Further, Shining3D Corporation

reserves the right to revise this publication and to make changes from time to time in

the contents hereof without obligation of Shining3D Corporation to notify any person of

such revision or changes.

⚫Updates to hardware and/or software components are made regularly; therefore,

some of the instructions, illustrations, and specifications mentioned in the Manual may

differ slightly from your particular situation.

 
 
Aoralscan 3_Manual_V1.0.0.30 - 3 -
Table of Contents 
Foreword...............................................................................................- 1 -
1. Read This First ............................................................................- 1 -
 Basic Information .................................................................- 1 -
 Intended Use .......................................................................- 4 -
 Contraindications .................................................................- 5 -
 Warnings .............................................................................- 5 -
 Waste Electrical and Electronic Equipment .............................- 6 -
 Disposal...............................................................................- 6 -
 Warranty .............................................................................- 7 -
 Contact Information .............................................................- 7 -
2. Safety Information......................................................................- 8 -
 Precautions..........................................................................- 8 -
 Legend of Labels and Symbols................................................- 9 -
2.2.1. On the Scanner ............................................................- 10 -
2.2.2. On the Scanner/Carry Box/Package................................- 10 -
 Compliance........................................................................- 11 -
 FCC Compliance Statement..................................................- 11 -
 Electrical Safety..................................................................- 11 -
2.5.1. Electrical .....................................................................- 11 -
2.5.2. Classification................................................................- 12 -
2.5.3. EMC Notice..................................................................- 13 -
 Biological Safety .................................................................- 20 -
 Laser Protection .................................................................- 20 -
3. Unpack the Package..................................................................- 22 -
4. Overview .................................................................................- 24 -
 Benefits of the Product .......................................................- 24 -
 Scanner Overview...............................................................- 24 -

 
 
Aoralscan 3_Manual_V1.0.0.30 - 4 -
4.2.1. Scan head and scanner body .........................................- 24 -
4.2.2. Scanner Pedestal..........................................................- 25 -
4.2.3. Relay box.....................................................................- 25 -
4.2.4. Main Cables.................................................................- 26 -
 Software Overview .............................................................- 27 -
4.3.1. System requirements....................................................- 27 -
4.3.2. Installing the software programs ...................................- 28 -
5. Setting the Scanner...................................................................- 29 -
 Connecting the Scanner ......................................................- 29 -
 Disconnecting the Scanner ..................................................- 30 -
 Calibrating the Scanner .......................................................- 30 -
6. Scanning Preparations...............................................................- 33 -
 Intraoral Environment.........................................................- 33 -
 Scanner Preparation ...........................................................- 33 -
 Scanning Position and Path..................................................- 33 -
 Heating the Scanner Head ...................................................- 34 -
7. Clinical Case Quick Guide...........................................................- 36 -
 Connect the Scanner...........................................................- 36 -
 Activate the Scanner...........................................................- 36 -
 Calibration.........................................................................- 36 -
 Register Account ................................................................- 36 -
 Create Orders.....................................................................- 36 -
 Scan Upper Jaw ..................................................................- 37 -
 Scan Lower Jaw ..................................................................- 38 -
 Scan Total Jaws ..................................................................- 38 -
 View Result Data ................................................................- 40 -
7.9.1. View Upper/Lower Jaw .................................................- 40 -
7.9.2. View Occlusal Effect .....................................................- 41 -

 
 
Aoralscan 3_Manual_V1.0.0.30 - 5 -
 Pre-Design .........................................................................- 42 -
 View Data Storage Path.......................................................- 42 -
 Upload Order .....................................................................- 42 -
8. Care and Maintenance ..............................................................- 43 -
 Pre-cleaning, Disinfection, and Sterilization...........................- 43 -
 Scanner Pedestal Care.........................................................- 44 -
 Scanner Body Care..............................................................- 44 -
 Scanner Head Care .............................................................- 46 -
8.4.1. Cleaning and high-level disinfection ...............................- 46 -
8.4.2. Cleaning and steam sterilization ....................................- 48 -
8.4.3. Attaching the scanner head...........................................- 49 -
 Scanner Storage .................................................................- 50 -
8.5.1. Storage for Transport ...................................................- 50 -
8.5.2. Daily and Long-term Storage .........................................- 51 -
9. Hardware Specification .............................................................- 52 -
 Specifications.....................................................................- 52 -
 Environmental Requirements ..............................................- 52 -
 
 

Aoralscan 3_Manual_V1.0.0.30 - 1 -

1. Read This First

The Manual provides important procedures and information on how to operate the scanner

and configure the IntraoralScan software correctly and safely. Before attempting to operate the

product, read the Manual and strictly observe all warnings and cautions. Pay extra attention to

the information from Safety information in chapter 2.

Basic Information

A. Product name, model

Product name: IntraoralScan

Model: Aoralscan 3

Name, residence, contact information and after-sales service of the registrant or the filer:

Registrant's name: SHINING 3D Tech Co., Ltd.

After-sales service provider: SHINING 3D Tech Co., Ltd.

Name, residence, contact information and after-sales service of the manufacturer

Manufacturer name: SHINING 3D Tech Co., Ltd.

Production Address: No. 1398, Xiangbin Road, Wenyan, Xiaoshan, Hangzhou, Zhejiang, China,

311258

Product performance, main structural composition

Product performance

- Appearance and structure

The appearance should be smooth, no cracks, no stains, no obvious deformation, flexible and

reliable operating mechanism.

- Function control and display

Function control: After pressing the scanning button, determine whether the front end of the

scanner flashes normally.

Display: Under normal working conditions, when the scanner is opened for scanning, the two-

dimensional and three-dimensional imaging of the scanned object (such as teeth) can be seen on

the display respectively.

3D image processing: After the 3D stereo image is generated, the 3D image can be cropped

Aoralscan 3_Manual_V1.0.0.30 - 2 -

as needed by using the relevant buttons on the top, bottom and right side.

- Performance

Posterior groove teeth scanning and imaging: Under normal operating conditions, the

scanner can scan and image human posterior alveolar teeth to form a 3D digital model.

Irradiance: Under normal use of the intraoral scanner, the irradiance is not greater than

1mW/cm2.

Accuracy: Under normal conditions, the scanner is used to scan against a standard (e.g., a

plaster standard known to be similar in size to a tooth), obtain its three-dimensional stereoscopic

data, and measure key dimensions to obtain measured values.

Heating of the entrance part of the scanning head: Under normal working conditions, the

intraoral scanner should have heating and anti-fogging function when entering the mouth under

working condition.

- Data interface

USB 3.0, data storage format shall include 3D digital model format .stl and .obj.

Main structural composition

The Scanner consists of Scanner body, scanner head, relay box, adapter, pedestal, USB cable,

software (V1.0), and encryption module. The software carrier is USB flash drive, and the software

release version is V1.0. After the power is switched on, ensure that the relay box and scanner are

powered on. When the power is on, the relay box indicator is green.

Attention

⚫It is recommended that users copy the software from the USB flash drive to the

computer hard disk before installing the driver.

⚫Use Nvidia graphics cards to get the highest scanning efficiency.

⚫Do not insert wireless USB network card in the computer, USB wireless network card

will lead to USB bandwidth occupation, affecting the normal work of the camera.

VI. Product maintenance and care methods, special storage/transportation conditions,

operating conditions.

1) The product does not work in the state as far as possible not to open, the need for water

and moisture.

2) The need to use dustproof cover when sitting.

Aoralscan 3_Manual_V1.0.0.30 - 3 -

3) After using scanner head, use alcohol to wipe and then use autoclave to sterilize it. (121°C,

102.9kPa for 30 minutes; 134°C, 205.8kPa for 4 minutes). Use alcohol to wipe the scanner cover.

Use dust-proof cloth to wipe the scanning window to ensure the window keeps dry.

4) Operating temperature: 10°C to 40°C, relative humidity: 30%–75%.

5) Storage/transport temperature: -25°C to 60°C, relative humidity: 30%–75%.

6) Air pressure: 86 kPa–106 kPa.

Note

The temperature and humidity and atmospheric pressure conditions for

storage/transportation are reflected on the outer packaging.

VII. Production date, use by date or expiration date

The production date is shown on the product label. Use period: 8 years.

Eight, the list of accessories, including accessories, accessories, wear and tear replacement

cycle and instructions on how to replace.

Scan head as a wear and tear products can be autoclaved up to 20 times, after which it needs

to be replaced. Replacement method is as follows.

(1) Disconnect the scanner power, hold the scanning head firmly with thumb and index finger

on both sides, and then gently slide the scanning head out of the scanner as shown in the figure.

(2) Hold the scan head firmly with your thumb and index finger on either side and gently

attach the scan head to the scanner with the head facing down.

CAUTION

Do not place your fingers on the lens of the scan head when removing and attaching the scan

head, because this might cause damage to the lenses.

(3) Try to gently shake the scan head to ensure that it locks into place and is stable.

CAUTION

The Aoralscan 3 intraoral scanner should not be used in close proximity or stacked with other

equipment, and if it must be used in close proximity or stacked, observe to verify proper operation

in the configuration in which it is used.

Class A equipment is intended for use in industrial environments where it may be potentially

difficult to ensure electromagnetic compatibility in other environments due to conducted and

radiated disturbances from the Aoralscan 3 intra-oral scanner.

Aoralscan 3_Manual_V1.0.0.30 - 4 -

The use of accessories and cables other than those specified may result in increased

emissions or reduced immunity of the Aoralscan 3 intraoral scanner, except for cables sold by the

manufacturer of the Aoralscan 3 intra-oral scanner as spare parts for internal components.

Interruptions during electrostatic testing can be recovered within 5s without affecting basic

performance.

Intended Use

This is an intraoral scanner that works with the supplied software programs. With Intraoral

Scanner, you can perform intraoral scanning directly and digitally acquire and save the 2D/3D color

images of a patient's teeth and gingiva for the orthodontic, implant, and restoration use. The

scanner kit is composed of: Scanner head, scanner body, pedestal, power adapter, USB cable, relay

box, USB flash drive (with IntraoralScan software inside, V1.0) and dongle.

Note:

⚫Benefits to be achieved: As a device that applies a probing optical scanning head, this

scanner can directly scan inside the patient's mouth to obtain three-dimensional

morphology and color texture information of soft and hard tissue surfaces such as

teeth, gums, and mucous membranes in the oral cavity, facilitating comfortable mold

taking for patients, reducing stress for medical care, and improving efficiency for back-

end processing.

⚫The scanner satisfies related requirements.

WARNINGS

⚫Do not use the scanner for purposes other than those intended and expressly stated

above.

⚫This product is designed and intended for use by persons with professions of dentistry

and dental laboratory technology. The product cannot be operated by the patients themselves.

The user is solely responsible for determining whether the scanner is appropriate for a particular

patient case.

⚫Do not misuse the scanner, and do not use or operate the software programs incorrectly.

⚫The clinical environments where the scanner and the software programs can be used

include dental clinics, dental hospitals, and dental laboratories.

⚫Only trained medical personnel may use the scanner and the supplied software

programs.

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